A Phase 4 interventional study of VERDYE powder for solution for injection 25 mg in Laparoscopic Cholecystectomy, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Phase 4, Interventional, and Treatment
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.
Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Excipients
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Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
Drug: VERDYE powder for solution for injection 25 mg
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Drug: VERDYE powder for solution for injection 25 mg
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
Drug: VERDYE powder for solution for injection 25 mg
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Drug: VERDYE powder for solution for injection 25 mg
Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.
Also known as: Indocyanine green (ICG)
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Time frame: During surgical procedure, after dissection of the hepatocystic triangle.
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure, after the disection of the hepatocystic triangle has begun.
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery
Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.
Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Time frame: During surgical procedure
The annual rate of LC in the two hospitals in the study is over 300 surgeries per year. In order to recruit 200 in both centres, a review waiting list will be conducted. Patients who meet the inclusion criteria will be given the necessary information and, after signing the informed consent form, will be included in the trial.
| Milestone | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| Started | 49 | 45 | 44 | 62 |
| Completed | 47 | 45 | 44 | 60 |
| Not completed | 2 | 0 | 0 | 2 |
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| Category 1 | 26 | 20 | 26 | 29 |
| Category 2 | 32 | 25 | 28 | 36 |
| Category 3 | 15 | 12 | 18 | 19 |
| Category 4 | 23 | 19 | 25 | 19 |
| Category 5 | 16 | 16 | 16 | 25 |
| Category 6 | 2 | 1 | 1 | 0 |
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| Category 1 | 40 | 38 | 36 | 45 |
| Category 2 | 42 | 33 | 35 | 48 |
| Category 3 | 41 | 35 | 36 | 40 |
| Category 4 | 41 | 35 | 36 | 40 |
| Category 5 | 24 | 26 | 25 | 36 |
| Category 6 | 6 | 5 | 5 | 3 |
Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| 1=little | 12 | 20 | 12 | 25 |
| 2=sufficient | 11 | 7 | 4 | 11 |
| 3=quite a bit | 6 | 5 | 9 | 3 |
| 4=good | 11 | 7 | 10 | 13 |
| 5=excellent | 7 | 6 | 9 | 8 |
Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| 1=little | 6 | 6 | 5 | 13 |
| 2=sufficient | 6 | 12 | 6 | 10 |
| 3= quite a bit | 8 | 4 | 5 | 5 |
| 4= good | 12 | 6 | 15 | 15 |
| 5= excellent | 15 | 17 | 13 | 17 |
Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| 0= not useful | 4 | 9 | 3 | 13 |
| 1= moderately useful | 22 | 24 | 19 | 23 |
| 2= very useful | 21 | 12 | 22 | 24 |
Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
| Participants | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min |
|---|---|---|---|---|
| Cat 0 | 26 | 12 | 26 | 7 |
| Cat 1 | 16 | 17 | 13 | 20 |
| Cat 2 | 4 | 4 | 5 | 15 |
| Cat 3 | 1 | 9 | 0 | 9 |
| Cat 4 | 0 | 3 | 0 | 9 |
Collected over The adverse event collection period in this study extends from the time of surgery until one month postsurgery.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Number of Patients | 0/196 (0%) | 13/196 (6.6%) | 66/196 (33.7%) |
| Event | Total Number of Patients |
|---|---|
| Intraabdominal fluid collectionInfections and infestations | 2/196 |
| AdenocarcinomaHepatobiliary disorders | 1/196 |
| Atrial fibrillationCardiac disorders | 1/196 |
| Heart failureCardiac disorders | 1/196 |
| HypersensitivityImmune system disorders | 1/196 |
| Acute pancreatitisGastrointestinal disorders | 1/196 |
| Abdominal painGastrointestinal disorders | 1/196 |
| Ileus paralyticGastrointestinal disorders | 1/196 |
| CholecystitisGastrointestinal disorders | 1/196 |
| CholangitisGastrointestinal disorders | 1/196 |
| Event | Total Number of Patients |
|---|---|
| VomitingGastrointestinal disorders | 14/196 |
| DiarrhoeaGastrointestinal disorders | 5/196 |
| PyrexiaGeneral disorders | 4/196 |
| HeadacheNervous system disorders | 4/196 |
| PhlebitisVascular disorders | 3/196 |
| HaematomaVascular disorders | 3/196 |
| COVID-19Infections and infestations | 3/196 |
| InfectionInfections and infestations | 3/196 |
| EcchymosisVascular disorders | 2/196 |
| PainGeneral disorders | 2/196 |
Of the 200 overall number of baseline participants, 196 completed the study; therefore, only the results and data obtained from these 196 subjects were used for the corresponding statistical analyses
| Age, Customized(participants) | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min | Total |
|---|---|---|---|---|---|
| Between 20 and 91 years | 47 | 45 | 44 | 60 | 200 |
| Sex: Female, Male(Participants) | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min | Total |
|---|---|---|---|---|---|
| Female | 33 | 25 | 25 | 38 | 121 |
| Male | 14 | 20 | 19 | 22 | 75 |
| Race and Ethnicity Not Collected(Participants) | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Body mass index (BMI)(Kilogram per square meter) | Fixed Dose 3 Hours | Fixed Dose 30 Min | Weight-adjusted Dose 3 Hour | Weight-adjusted Dose 30 Min | Total |
|---|---|---|---|---|---|
| Mean | 30.5 ± 6.3 | 27.1 ± 4.8 | 28.9 ± 6.6 | 28.4 ± 7.1 | 27.9 ± 8.2 |
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Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Informed consent form
Time frame: From the date of publication of the results.
Access criteria: Through access to the journal where the results are published.
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Studies of the drug tested here: Indocyanine Green
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León